The present invention relates to pharmaceutical and cosmetic cream compositions containing Dead Sea Mud for topical skin application. More specifically, the present invention relates to compositions for prevention and treatment of skin related disorders such as saborrehic dermatitis, xerosis, eczema, psoriasis and skin burns and for cosmetic use for retaining skin moisture and repairing of impaired skin.
The skin is the largest organ in the body, serving as a protective barrier from the external environment. As such it is susceptible to various disorders and diseases caused by microorganisms, exposure to radiation, contact with irritating materials and loss of water.
Dead Sea mud and water are known for their therapeutic and cosmetic properties (for example see Ma""or Z. and Yehuda S. (1997) International Journal of Cosmetic Science 19: 105-110). Various cosmetic products based on these properties exist in the market. For example, Japanese application JP 96011775 discloses a beauty plaster, comprising among other ingredients, natural salt and mud from the Dead Sea. PCT application No. PCT/IL98/00311 (applicant: Dead Sea Laboratories Ltd.) discloses a composition for skin care and protection comprising 10-15% of Dead Sea water.
Dead Sea mud is especially known for its therapeutic properties on psoriasis and other skin related disorders. Patients, suffering from various skin diseases come to the Dead Sea to have treatments with Dead Sea Mud, often upon their physician recommendation.
However, treatment with raw Dead Sea Mud has several drawbacks. It may be quite expensive and inconvenient for patients to travel to the Dead Sea for receiving treatment. The other possibility, delivering raw mud to the patient""s home, is inconvenient due to the large amounts that must be applied for each treatment (10 Kg). Furthermore, the treatment with Dead Sea mud is quite messy and is limited to short time periods, since the mud cannot be left on the body for long periods of time due to inconvenience and aesthetic reasons.
It is the aim of the present invention to overcome the problems associated with treatments with Dead Sea water by providing an easy and pleasant to use creams that while having the therapeutic benefits of the Dead Sea mud do not suffer from the above mentioned disadvantages.
The incorporation of mud (in our case, Dead Sea mud) into a leave-on cream which should be evenly spreadable, aesthetic (i.e., unnoticeable), pleasant to use and absorbed easily to the skin, is not simple, because it involves a suspension of solid particles in an oil-in-water emulsion that contains electrolytes in a very high concentration. Such a combination has a high tendency to aggregate and to separate into phases. Still the cream must be stable and with a reasonable shelf life.
The present invention overcomes said difficulties by proper selection of stabilizers and other components, and provides a cream that has the benefits of treatment with Dead Sea mud, but non of the drawbacks. It is an easy and simple to use hypoallergenic cream that is absorbed into the skin and in contrast to the treatments used today, it may be in prolonged contact with the skin (i.e., leave-on cream), enhancing the beneficial effects of the Dead Sea mud. It is also stable, does not separate to phases, and has long shelf life.
In the context of the present invention the term xe2x80x9ccosmetic creamxe2x80x9d relates to an oil-in-water emulsion, suitable for applying to skin, of various viscosity ranges including milk, lotion, cream and ointment.
The term xe2x80x9cpharmaceutical creamxe2x80x9d relates to an oil-in-water emulsion of various viscosity including milk, lotion, cream and ointment for the use of treating (healing) and preventing or delaying skin disorders and diseases.
The term xe2x80x9cleave on creamxe2x80x9d (in contrary to xe2x80x9crinse offxe2x80x9d) relates to a cream that may be in prolonged contact with the skin and can be applied to the skin without the need to wipe it off in any way.
The present invention relates to a pharmaceutical cream composition for topical application for the treatment of skin disorders and skin diseases, comprising 1-6 wt. % Dead Sea Mud as an active ingredient. Said composition is for use in treating skin disorders and skin diseases such as psoriasis, saborrehic dermatitis, xerosis, attopic dermatitis, eczema, diaper rush, skin burns of stage I and sensitive skin.
Said cream composition is also for use as a leave-on cosmetic cream for beautifying and enhancing the skin appearance.
In addition to Dead Sea Mud said composition comprises ingredients suitable for the preparation of cosmetic cream.
In a preferred embodiment, said ingredients are selected from Octyl Palmitate, Cetearyl Alcohol, Ceteareth-30, Hexadeacanol, Glyceryl Stearate, Glycerin, PEG-40 Stearate, Zinc Oxide, Propylene Glycol, Aloe Barbadensis Extract, Dimethicone, Sorbitan Tristearate, Allantoin, Methylparaben, Propylparben, Vitamin E (Tocopherol), Bronopol.
Said cream can further comprises up to 4 wt % Dead Sea water.
The present compositions can further contain a fragrance.
The present invention relates to pharmaceutical cream composition for topical application for the treatment of skin disorders and skin diseases, comprising 1-6 wt. % Dead Sea Mud as an active ingredient. Said composition is also for use as a cosmetic leave-on composition for beautifying and enhancing the skin appearance.
Said composition is prepared by adding 1-6 wt. % Dead Sea Mud and optionally up to 4% Dead Sea water to cosmetic oil-in-water emulsion comprising of ingredients suitable for the preparation of a cosmetic cream such as ingredients selected from Octyl Palmitate, Cetearyl Alcohol (and) Ceteareth-30, Hexadeacanol, Glyceryl Stearate, Glycerin, PEG-40 Stearate, Zinc Oxide, Propylene Glycol (and) Aloe Barbadensis Extract, Dimethicone, Sorbitan Tristearate, Allontoin, Methylparaben, Propylparben, Vitamin E (Tocopherol), Bronopol and fragrance.
The present composition was found to be efficient in the treatment of the following skin disorders and diseases: Psoriasis, Saborrehic dermatitis, Xerosis (very dry skin), Attopic dermatitis, Eczema, Diaper rush, sensitive skin, and skin burns of stage I.
Dead Sea Mud (Silt) as defined in the present invention is (at 25xc2x0 C.) stable black paste solid with specific density of 1.6-1.8 g/ml, pH=6.4-7.6, Water content of 30-40 %/w and less than 100 cfu/gr and non-pathogenic microbes. The chemical identity of Dead Sea mud is natural sediment, mixture of solid mineral clays with interstitial solution of inorganic salts and sulfide compounds originated from microbiological activity, with particle size 86-98%  less than 0.005 mm, 2-9% 0.005-0.02 mm, 0-7%  greater than 0.02 mm.
The major constituents of the Dead Sea Mud are:
The solid phase which is 60-70% of the total weight consists of:
Water soluble: Halite (20-40%)
HCl soluble: Carbonates (30-40%): calcite, dolomite, aragonite
Non HCl-Soluble matter: Silicates (30-40%): quarts, montmorollonite, feldspar, kaolonite
In the liquid phase (30-40% dissolved as ions in water):
chloride (Clxe2x88x92)148-190 g/l
sodium (Na+) 22-32 g/l
magnesium (Mg2+) 30-40 g/l
calcium (Ca2+) 10-15 g/l
potassium (K+) 6-8 g/l
Dead Sea Water, as defined in the present invention, comprises a clear colorless viscous liquid (at 25xc2x0 C.) with a specific density of 1.2-1.36 g/ml, pH=4.5-5.5 (at 25xc2x0 C.), less than 100 cfu/gr and non pathogenic microbes.
The major constituents of the Dead Sea Water are:
The preparation of creams according to the present invention involves the facilitation of non-ionic emulsifiers such as ethoxilated sorbitan esters, sorbitan esters, ethoxilated alcohols or fatty acids, alkyl glucosides, mono- and di-glycerides etc.
A preferred embodiment of a cream composition according to the present invention is given in the following Table 1.
Table 1. Raw Ingredients List of preferred embodiment of the present invention:
The preparation of the cream composition of the present invention is preferably done by the following steps:
1) Preparing an aqueous phase comprising distilled water, allanotin, methyl paraben, PEG-40 sterarate and glycerin by mixing said components and heating to 75xc2x0 C.
2) Preparing a lipophilic phase comprising octyl palmitate, cetearyl alcohol, ceteareth-30, hexadeacanol, glyceryl stearate, zinc oxide, propylene glycol, dimethicone, sorbitan tristearate, propylparben, and vitamin E (tocopherol), by mixing at 75xc2x0 C.
3) Introducing the lipophilic phase dropwise into a reactor containing the aqueous phase (the distance between the rotor and the stator is adjusted to 4 mm) while stirring at 30 rpm and homogenizing the mixture at 1500 rpm.
4) Cooling said mixture obtained in step 3 slowly and adding following components at following temperatures through homogenization,
5) Adding bronopol dissolved in water at 60xc2x0 C.
6) Adding the fragrance at 45xc2x0 C.
7) Adding Aloe Barbadensis extract at 35xc2x0 C.
8) Adding Dead Sea Mud and Dead Sea Water at 25xc2x0 C.
9) Removing from the reactor to suitable containers.
The composition so obtained is a gray light cream with ingredients concentrations as specified in Table 1 and with the following properties:
Density: 1.00xc2x10.1 g/ml; Viscosity as determined by Brookfield viscometer with needle c: 108,600 cps at 5 rpm and 190,400 cps at 2.5 rpm; pH: 7.0xc2x10.5 and less than 100 cfu/gr. The cream is stable and does not separate into phases and has a shelf life of 3 years.
The present invention will be further illustrated by the following experiments. These experiments do not intend to limit the scope of the invention, but to demonstrate and clarify it only.